Skip to main content
Sister Publication Links
  • European Rubber Journal
  • Plastics News
  • Tire Business
web
Subscribe
  • Login
  • Register
  • Subscribe
  • News
    • Automotive
    • Tire
    • Non-Tire
    • Suppliers
    • Silicone
    • Latex
    • Coronavirus
    • Executive Action
    • Government/Legal
    • Opinion
    • Technical Notebooks
    • Women in Tire & Rubber
    • ITEC
    • International Elastomer Show
    • HEXPOL Sponsored Content
    • Israel's Tactile Mobility launches tire insight technology
      Bidirectional EVs could lend a hand in power crisis
      WDK: German rubber industry set for double-digit growth in 2021
      Dana acquires electronics and software provider Pi Innovo
    • Israel's Tactile Mobility launches tire insight technology
      Goodyear joins EASE Logistics, Ohio city to launch connected mobility pilot program
      Goodyear to raise prices on passenger tires
      Ryan Patterson to lead Goodyear-Cooper integration efforts
    • Smithers opens doors to new medical device testing lab
      Maine's Poly Labs doubles work force
      Foam shortage a major concern for auto makers, seating suppliers
      New Products: Kraiburg launches advanced, ‘supersoft' TPEs
    • Emerald to close Illinois rubber additives site
      Smithers opens doors to new medical device testing lab
      Dana acquires electronics and software provider Pi Innovo
      Gelest's Barry Arkles enters National Academy of Engineering
    • Gelest's Barry Arkles enters National Academy of Engineering
      ECO starts 'first' U.S. silicone rubber recycling plant
      New legacy taking shape at Stockwell Elastomerics
      Fenner opens new textile treatment line in Pennsylvania
    • Ohio firm focuses on making better masks in U.S.
      U.S. to increase NBR, make gloves using Defense Production Act
      Tire Cologne canceled; rescheduled for 2022
      Tire Technology Expo canceled for 2021
    • Ryan Patterson to lead Goodyear-Cooper integration efforts
      New legacy taking shape at Stockwell Elastomerics
      Davis-Standard promotes Andrew Alaya to aftermarket sales role
      Harwick Standard adds Flores to West Coast sales team
    • Bidirectional EVs could lend a hand in power crisis
      Braskem Idesa reopens PE complex in Mexico with new contract
      To boost U.S. microchip production, Biden administration must find supply chains weaknesses
      TIA among associations against increase to minimum wage
    • Column: Value is the stuff in custom mixing
      New legacy taking shape at Stockwell Elastomerics
      Column: Discussions of race, equality may mean uncomfortable moments
      Column: Business trips possible because of essential workers
    • Part 2: Studying RPA ASTM methods for detecting compound quality differences
      Studying RPA ASTM methods for detecting compound quality differences
      Damage mechanism in oil and gas formulations during downhole testing
      Advancements in synchronous drive belt design for industrial and consumer markets
    • Rubber Division introduces WORD webinar series
      WORD panelists say evolution, authenticity keys to success
      New video celebrates women in rubber industry
      ITEC panelists say women can thrive in tire industry
    • Goodyear recognized by Lockheed Martin as 'elite supplier'
      EV tire advancements to help secure future
      Lambillotte: Only question on AVs is timing
      CAR official says EV future brighter than autonomous
    • Rubber Division introduces WORD webinar series
      Rubber Division seeks abstracts for 200th Technical Meeting
      WORD panelists say evolution, authenticity keys to success
      IEC keynote: Communication key to logistics
    • Sponsored By HEXPOL Compounding
      Faster Access to Your Polymer Compounding Experts Around the World
      Sponsored By HEXPOL Compounding
      Take a walk thru a HEXPOL Lab
      Sponsored By HEXPOL Compounding
      HEXPOL offers a unique selection of High Performance Elastomers to match your application requirements
      Sponsored By HEXPOL Compounding
      It’s what you can’t see that makes the Difference at HEXPOL
  • Blogs
    • Products
    • Wacky World of Rubber
    • New Products: Kraiburg launches advanced, ‘supersoft' TPEs
      New Products: Mahr Inc. introduces MarForm MMQ 500 Form Tester
      New Products: Starrett expands field-of-view for multi-sensor vision system
      New Products: Nova thinks outside the box with sealing tech
    • Wacky World of Rubber: How Trelleborg, teens sealed a spot in the world record book
      Wacky World of Rubber: Of chicken and feet, but not chicken feet
      Wacky World of Rubber: Time to go mattress shopping
      Wacky World of Rubber: Because nothing says football like 'frunk' shrimp
  • Newsletters
    • Rubber in Automotive
    • Silicone News
    • Latex News
    • Sign Up for Newsletters
    • Israel's Tactile Mobility launches tire insight technology
      Bidirectional EVs could lend a hand in power crisis
      WDK: German rubber industry set for double-digit growth in 2021
      Dana acquires electronics and software provider Pi Innovo
    • Gelest's Barry Arkles enters National Academy of Engineering
      ECO starts 'first' U.S. silicone rubber recycling plant
      New legacy taking shape at Stockwell Elastomerics
      Fenner opens new textile treatment line in Pennsylvania
    • Top Glove eyes new expansions with Hong Kong listing
      Sri Trang Gloves starts major capacity expansion
      Synthomer dismisses takeover reports
      Combined Goodyear-Cooper Tire company has tire technology, sustainability edge
  • Multimedia
    • Videos
    • Photo Galleries
  • Directory
  • Resources
    • Classifieds & Mold Mart
    • Sponsored Content
    • White Papers
    • HB Chemical
      Sponsored By HB Chemical
      The HB Chemical and Ravago Partnership: Taking Customer Service to a New Level
      Sponsored By HB Chemical
      Above and Beyond with HB Chemical
      Sponsored By HB Chemical
      The Company Behind the Inventory
      Sponsored By French Oil Mill Machinery
      Process Improvement, Cost Reduction with Custom Press Systems
    • Sponsored By Uncountable Inc.
      Labs of the Future: How to Choose a Laboratory Information Management System in 2021
      Sponsored By Uncountable Inc.
      Cooper Standard deploys lab informatics platform to synchronize R&D
      Sponsored By Elkem
      LSR Select™: A solution to improve your financial impact in molding applications
      Sponsored By HEXPOL Compounding
      Peroxide Cureable Silicone Injection Molding
  • Data
  • Events
    • RPN Events
    • RPN Livestreams/Webinars
    • Industry Events
    • Past Events
    • ITEC Library
    • International Silicone Conference Library
    • 2021 Healthcare Elastomers Virtual Edition
      2021 Rubber in Automotive Virtual Edition
      2021 International Latex Conference Virtual Edition
      2022 ITEC
  • Advertise
  • DIGITAL EDITION
MENU
Breadcrumb
  1. Home
  2. Suppliers
March 08, 2020 12:39 PM

PolyOne's new TPE tackles medical tubing constraints

Catherine Kavanaugh
  • Tweet
  • Share
  • Share
  • Email
  • More
    Print
    PolyOne Corp.
    A technician takes a sample for a cell culture from a biotechnological bioreactor in a microbiological laboratory. These health care processes and others rely on biopharmaceutical tubing.

    ANAHEIM, Calif.—PolyOne Corp. is out with a new medical grade of thermoplastic elastomer in response to shortages of siloxane, a key ingredient of silicone, and the closure of some large-scale sterilization facilities.

    The Avon Lake, Ohio-based compounder and concentrate maker launched a new formulation of Versaflex—called HCBT218—at the Medical Design & Manufacturing West expo in Anaheim, with the focus of easing supply problems.

    The siloxane supply has been constrained since 2017 by environmental regulations, particularly in China, work stoppages due to mechanical breakdowns and complete shutdowns. Producers also have been slow to add capacity.

    Last year, the U.S. Food and Drug Administration issued several warnings about shortages of medical tubing and devices after some sterilization facilities were closed for emitting unsafe levels of ethylene oxide, which is a carcinogen, into the air around their sites.

    These constraints have led to higher prices, longer lead times and increased interest in silicone alternatives.

    "People are asking: 'Do I really need silicone?' For a lot of applications, we're finding they don't," said Russell Danielson, PolyOne's senior marketing manager. "Silicone is great if you need a high level of really low compression set or very high temperature resistance, but it is essentially over-engineered for a lot of uses."

    In response to supply and sterilization issues, Danielson said PolyOne formulated a new kind of Versaflex TPE for biopharmaceutical tubing applications that offers weldability, kink resistance and tensile strength performance comparable to leading medical tubing materials, including silicone and TPEs.

    The new grade of Versaflex can be utilized for most medical tubing applications, such as peristaltic pumps, IV drug delivery, infusion pumps and other applications that involve moving pharmaceuticals between bags, bottles and patients. However, it was developed specifically to address the needs of the biopharmaceutical manufacturing process, in which fluids must be transported from one bioreactor to another during drug development and processing.

    Just ahead of the product launch, Jim Mattey, PolyOne's global marketing director of specialty engineered materials, said the expanded Versaflex line allows customers to innovate and meet market needs.

    "We are committed to leveraging our material science expertise to formulate alternative and customized solutions that meet regulatory demands and functional necessity for lifesaving medical devices, especially in the face of market uncertainties," Mattey said.

    Supply chain concerns

    The FDA is monitoring closely the supply chain effects of closures and potential closures of facilities that use ethylene oxide to remove potentially harmful germs and other microorganisms prior to use.

    The agency said it is concerned about the future availability of sterile medical devices and the potential shortages that might impact patient care.

    More than 20 billion devices sold in the U.S. every year are sterilized with ethylene oxide, accounting for about 50 percent of devices that require sterilization, according to the FDA.

    The medical device industry, FDA, U.S. Environmental Protection Agency and state authorities have been at odds about how to balance production needs and environmental impacts of ethylene oxide sterilization facilities.

    The spokesman for the Advanced Medical Technology Association—known as AdvaMed—on Feb. 18 urged the Environmental Protection Agency to abandon EtO risk assessment value for one that is more feasible, based on the best available science, and one that will not endanger public health by threatening the availability of needed medical technologies.

    "Anyone studying this issue can see that the EPA standard is impractical and does not meet the definition of good science," said Scott Whitaker, AdvaMed president and CEO. "The medical technology industry is committed to the safe and responsible use of EtO, even as we look for alternatives and ways to reduce EtO emissions. However, the EPA's risk standard sets an unreasonable threshold that will only threaten the continued availability of tens of billions of the EtO-sterilized medical technologies patients depend on."

    Closures add up

    The most recent closure was scheduled to occur by the end of 2019 at a Viant Medical sterilization operations in Grand Rapids, Mich., according to the company's consent order with the state of Michigan.

    Another closure happened Dec. 13 at a Medline Industries facility in Waukegan, Ill. This was a voluntary stop in operations to install emissions reduction equipment to bring the facility in line with ethylene oxide exposure standards Illinois approved last year, the FDA said.

    Before that, in October 2019, the Georgia State Attorney General requested the potential closure of a Becton Dickinson and Co. medical device sterilization facility in Covington, Ga., because of emissions. If it were to be closed, the FDA is concerned that significant additional strains to the supply chain for critical medical devices may lead to shortages of surgical kits, feeding tubes and a variety of catheters.

    Also in October 2019, the FDA said it learned a Sterigenics contract sterilization facility in Willowbrook, Ill., will not reopen after closing in February, while the company's facility in Atlanta temporarily remains closed for construction work to reduce ethylene oxide emissions.

    Meeting market needs

    PolyOne was able to commercialize its new grade of Versaflex in about nine months to meet demand for materials that can be sterilized with alternative methods.

    "There was pull from our customers to develop a new solution and we were able to move quickly," Danielson said. "Everything was lined up. The market was looking for something new, we had competency in this area from previous products, and we were able to put that all together with one of our key customers to mature the solution."

    To address another concern, PolyOne's health care formulations have no beeswax or animal-derived products such as bone-based additives.

    The new grade of Versaflex is commercially available in the U.S., as PolyOne awaits biocompatibility certifications for hemocompatibility, cytotoxicity, systemic toxicity and Class VI.

    The tubing compound is being manufactured in McHenry, Ill. PolyOne officials said as demand grows globally, the company can add production at other facilities.

    PolyOne operates 61 manufacturing sites and eight distribution facilities in North America, South America, Europe and Asia, with 5,600 employees. The company posted sales of $2.9 billion in 2019.

    Letter
    to the
    Editor

    Rubber & Plastics News wants to hear from its readers. If you want to express your opinion on a story or issue, email your letter to Editor Bruce Meyer at [email protected].

    SIGN UP FOR NEWSLETTERS
    EMAIL ADDRESS

    Please enter a valid email address.

    Please enter your email address.

    Please verify captcha.

    Please select at least one newsletter to subscribe.

    Get our newsletters

    Staying current is easy with Rubber & Plastics News delivered straight to your inbox, free of charge.

    Subscribe Today

    Subscribe to Rubber & Plastics News to get the best coverage and leading insights in the industry.

    SUBSCRIBE
    Connect with Us
    • LinkedIn
    • Facebook
    • Twitter

    MISSION

    To serve companies in the global rubber product industry by delivering news, industry insights, opinions and technical information.

    web
    Contact Us

    2291 Riverfront Pkwy, Suite 1000
    Cuyahoga Falls,
    OH 44221

    Customer Service:
    877-320-1726

    Resources
    • About Us
    • Digital Edition
    • Contact the Staff
    • Advertise
    • Order Reprints
    • Privacy Policy
    • Privacy Request
    • Terms of Service
    • Careers
    • Ad Choices Ad Choices
    • Sitemap
    Partner Sites
    • Tire Business
    • European Rubber Journal
    • Plastics News
    • Plastics News China
    • Urethanes Technology
    • Automotive News
    • Crain Brands
    Copyright © 1996-2021. Crain Communications, Inc. All Rights Reserved.
    • News
      • Automotive
      • Tire
      • Non-Tire
      • Suppliers
      • Silicone
      • Latex
      • Coronavirus
      • Executive Action
      • Government/Legal
      • Opinion
      • Technical Notebooks
      • Women in Tire & Rubber
      • ITEC
      • International Elastomer Show
      • HEXPOL Sponsored Content
    • Blogs
      • Products
      • Wacky World of Rubber
    • Newsletters
      • Rubber in Automotive
      • Silicone News
      • Latex News
      • Sign Up for Newsletters
    • Multimedia
      • Videos
      • Photo Galleries
    • Directory
    • Resources
      • Classifieds & Mold Mart
      • Sponsored Content
      • White Papers
    • Data
    • Events
      • RPN Events
      • RPN Livestreams/Webinars
      • Industry Events
      • Past Events
      • ITEC Library
      • International Silicone Conference Library
    • Advertise
    • DIGITAL EDITION